BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2013199 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02982
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT'S DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE FOR THE REPORT OF PERITONITIS WAS USE ERROR, POOR ASEPTIC TECHNIQUE. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE. A BATCH REVIEW FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (GD878199, GD879163, GD879908) REVEALED NO DEFECTS DURING MANUFACTURING. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE IN THE USA OF PERITONITIS COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT?S NURSE REPORTED THE FOLLOWING. ON (B)(4) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. ON AN UNREPORTED DATE IN (B)(6) 2011, PERITONEAL EFFLUENT CULTURES WERE OBTAINED, RESULTS WERE UNKNOWN. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT WAS DISCHARGED AND HAD RECOVERED. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING. PER THE NURSE, THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization DIANEAL PD4 ULTRABAG